Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

IF 0.3 Q4 PHARMACOLOGY & PHARMACY
E. Ortiz-Prado, E. Terán, Raul Patricio Fernandez Naranjo, Doménica Cevallos-Robalino, Eduardo Vasconez, A. Lister
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引用次数: 0

Abstract

At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic. The growing demand for a cure, the fear of dying from COVID-19, and the lack of therapeutic rigour, pushed a signifi cant number of people to seek help outside the traditional healthcare system. Doctors, pharmacists, and patients started prescribing or selfmedicating pharmacological products that were later shown to be ineff ective, toxic or even contraindicated. In Ecuador, most people who developed the severe acute respiratory syndrome associated with infection by the coronavirus 2 (SARS-CoV-2) virus, which causes COVID-19, used antibiotics (azithromycin), antiparasitic medications (hydroxychloroquine or ivermectin), dangerous chemical products (chlorine dioxide) and in some cases, biological medicines, to try to cure or protect themselves from COVID-19. The growing demand for therapies that were unavailable, as well as the rise in misinformation, created the perfect scenario for the misuse of medicines and enabled the appearance of a rampant black market of unregistered biological products. In this manuscript, we describe the Ecuadorian experience in relation to the off -label use of biological and biosimilar products during the COVID-19 pandemic, the role of the pharmaceutical black market, and the lack of national regulations to avoid dangerous practices. To the best of our knowledge this is the fi rst report that has aimed to describe the unapproved and even illegal sale and use of biologicals, biosimilars and related products, with or without approved therapeutic indications in the treatment of COVID-19.
针对COVID-19的生物技术疗法和生物仿制药:稀缺、监管不力和药品黑市:厄瓜多尔的案例分析
在COVID-19大流行开始时,厄瓜多尔对COVID-19病例的压倒性数量毫无准备。随着普通民众开始看到大流行的影响,民众开始寻求未经证实的治疗和药物,试图减轻大流行的影响。对治疗方法的需求日益增长,对死于COVID-19的恐惧,以及缺乏严格的治疗,促使相当多的人在传统医疗体系之外寻求帮助。医生、药剂师和患者开始开处方或自行用药,这些药物后来被证明是无效的、有毒的,甚至是禁忌的。在厄瓜多尔,大多数患有与冠状病毒2 (SARS-CoV-2)感染相关的严重急性呼吸系统综合征的人使用抗生素(阿奇霉素)、抗寄生虫药物(羟氯喹或伊维菌素)、危险化学产品(二氧化氯),在某些情况下还使用生物药物,试图治愈或保护自己免受COVID-19的感染。对无法获得的治疗方法的需求不断增长,以及错误信息的增加,为滥用药物创造了完美的场景,并使未经注册的生物制品黑市猖獗。在本文中,我们描述了厄瓜多尔在2019冠状病毒病大流行期间关于超说明书使用生物和生物类似药的经验、药品黑市的作用以及缺乏避免危险做法的国家法规。据我们所知,这是第一份旨在描述在治疗COVID-19时未经批准甚至非法销售和使用生物制剂、生物仿制药和相关产品的报告,无论是否有批准的治疗指征。
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来源期刊
CiteScore
1.80
自引率
0.00%
发文量
0
期刊介绍: The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.
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